anonymous
Guest
anonymous
Guest
Vote for Your Top Reason about Fezo delay:
1. FDA needed more time because they've never seen such an impactful drug and were too much in awe to do their job.
2. More discussion needed between FDA and Regulatory Affairs to be able to flippantly dismiss the negative Asian trial to the public.
3. Minor clarification needed on inconsequential liver side effects noted.
4. Crafting a black box warning on liver side effects is hard work.
5. Regulatory Affairs begged for a delay rather than a denial so they can look for a job while still receiving a paycheck.
6. Northbrook requested more time before denial to flesh out sales rep layoff plan.
7. Other? Note in comments below.
1. FDA needed more time because they've never seen such an impactful drug and were too much in awe to do their job.
2. More discussion needed between FDA and Regulatory Affairs to be able to flippantly dismiss the negative Asian trial to the public.
3. Minor clarification needed on inconsequential liver side effects noted.
4. Crafting a black box warning on liver side effects is hard work.
5. Regulatory Affairs begged for a delay rather than a denial so they can look for a job while still receiving a paycheck.
6. Northbrook requested more time before denial to flesh out sales rep layoff plan.
7. Other? Note in comments below.